Sr CRA I/ II – Melbourne

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.

Job Responsibilities:

• Performs site qualification, site initiation, interim monitoring, site management and close‑out visits ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilises available hardware and software to support the effective conduct of the clinical study data review and capture.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• Supports subject/patient recruitment, retention and awareness strategies.
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site‑level activities / communication to ensure project objectives, deliverables and timelines are met.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
• Ensures all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face‑to‑face meetings.
• Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow‑up actions.
• May provide direct supervision, training and/or mentorship to more junior level CRAs.
• Performs training and sign‑off visits for junior CRA staff, as assigned.
• May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager.

Qualifications:

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Moderate level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular basis.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.